Commercial concerns may influence whether clinical trials results are reported, says study

Commercial concerns may influence whether clinical trials results are reported, says study

A new University of British Columbia study published in the journal Clinical Therapeutics has found that drug companies who sponsor clinical trials in Canada exert influence in some cases over whether the results of clinical trials are reported. The study was based on interviews with trial investigators, research administrators and research ethics board members in BC, Alberta, and Ontario.

“There’s so much financial incentive for [companies] to report positive results and not to report negative results,” said one trial investigator interviewed for the study.

An estimated 4 in every 10 randomized controlled trials are not published in academic journals, according to a previous systematic review. Trials with less favourable results for the tested drug are less likely to be published—a phenomenon known as publication bias. This has led to less informed patient care and harms to patients.

“Our study highlights a number of ways drug companies can influence whether trial results are reported,” said lead author Richard Morrow. “Industry sponsors may negotiate clinical trial agreements that do not fully protect the right of investigators to publish, and a company’s control of data from a trial may hinder the ability of an investigator to report findings.”

If a company sponsoring a drug trial and lead investigators do not publish the results from a large multisite trial, a trial agreement may only allow an academic investigator from one trial site to publish results based on data from that site rather than data from the whole trial. That is unlikely to provide meaningful information about the primary outcome of the trial.

One trialist said he would only participate in trials where an academic research organization shared full access to the study data, saying, “Having shared access to the data is [one] way to protect against industry trying to . . . not get the information out there.”

The study also found that a company may stop a drug trial early and not report the results. According to a trialist involved in trials of cancer drugs who was interviewed for the study, a small biotech firm faced with negative trial results might even shut down as a company without completing ongoing trials or publishing trial findings.

In an editorial accompanying the article, Co-Editor-in-Chief of Clinical Therapeutics Jill Maron reflects, “The influence of pharmaceutical companies on data reporting, combined with the often seeming complacency of scientific journals to publish negative studies, have blurred the boundaries between fact and a biased interpretation of the facts.”

Interviews for the study were conducted between March 2019 and April 2021, and involved trialists from cardiovascular medicine, endocrinology, hepatology, infectious diseases, oncology, psychiatry, and rheumatology. None of the interviews related to COVID-19 trials.

The study was published in the February issue of Clinical Therapeutics and is available online at https://authors.elsevier.com/a/1eh9SXyUrzNYA. The journal’s accompanying editorial is available at https://www.clinicaltherapeutics.com/article/S0149-2918(22)00056-X/fulltext.

Contact for interviews: Alan Cassels, Communications Director, Therapeutics Initiative, Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia    mobile + 250.508.8996  Alan.Cassels@ubc.ca for Richard Morrow

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